FDA Approves New Indication for Xeljanz, Xeljanz XR
Xeljanz (tofacitinib; Pfizer) and Xeljanz XR (tofacitinib extended-release; Pfizer) have been approved by the Food and Drug Administration (FDA) to treat adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Xeljanz and Xeljanz XR are the first Janus kinase (JAK) inhibitors to be approved for both moderate to severe rheumatoid arthritis (RA) and now active PsA.
The new indication approval was based on data from the Phase 3 OPAL program, which included OPAL Broaden OPAL Beyond, and OPAL Balance. In the OPAL Broaden, 50% of patients taking Xeljanz achieved American College of Rheumatology 20 (ACR20) response vs 33% in the placebo group (P≤0.05) at 3 months. Similarly in OPAL Beyond, 50% of patients taking Xeljanz achieved ACR20 response vs 24% in the placebo group (P≤0.05) at 3 months.
Statistically significant improvements in ACR20 response was also seen with Xeljanz compared to placebo at Week 2, a secondary endpoint (OPAL Broaden: 22% vs 6%; P=0.0003; OPAL Beyond: 27% vs 13%; P=0.0046).
Safety results from the OPAL Broaden and Beyond studies were consistent with those observed in RA patients. Nasopharyngitis, upper respiratory tract infection, headache and diarrhea were the most common adverse events observed in >3% of Xeljanz patients.
Xeljanz is available as 5mg strength tablets and Xeljanz XR is available as 11mg strength extended-release tablets.
For more information call (800) 438-1985 or visit Xeljanz.com.